ToxStrategies


ToxStrategies is a multidisciplinary scientific consulting firm dedicated to developing innovative solutions for scientific, technical, and regulatory challenges. They apply sound science and tailor approaches to meet client needs, offering expertise in toxicology, risk assessment, environmental sciences, and more. Their mission is to provide scientific, strategic, and regulatory consulting to address complex health and safety issues across various industries.

Industries

biopharma
consulting

Nr. of Employees

medium (51-250)

ToxStrategies

Asheville, North Carolina, United States, North America


Products

Intentional Adulteration Rule food defense training

Training course that provides the curriculum necessary to become a qualified food defense individual under the Intentional Adulteration Rule.

Computational Toxicology Consulting Services

Consulting services applying computational toxicology to predict chemical toxicity, integrate high-throughput exposure and toxicity data, and inform chemical regulatory assessments.

New Approach Methods (NAMs) and Alternatives to Animal Testing

Consulting and safety assessment services utilizing new approach methods, in vitro, in chemico, and in silico data to support alternatives to traditional animal testing.

Rapid Exposure Estimation

Rapid exposure estimation consulting services utilizing novel approaches and strategies to quickly estimate human and environmental exposures across a wide range of chemicals, pathways, and receptors.

Ecological Risk Assessment and Ecotoxicology Consulting

Multidisciplinary consulting services providing screening-level and comprehensive environmental and ecological risk assessments, supported by subject matter experts in environmental fate, exposure, and ecological hazard.

Toxicology Monographs Consulting Services

Consulting services provided by board-certified toxicologists to prepare tailored toxicology monographs evaluating potential health hazards of product- and process-related impurities, degradants, solvents, and novel excipients in drug substances and drug products.

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Services

Consulting services to design and execute human health risk assessments for chemicals, products, and environmental contaminants.

Design and oversight of nonclinical toxicology programs and preparation of nonclinical sections of regulatory submissions (pre-IND, IND/CTA, NDA/BLA).

Implementation and interpretation of (Q)SAR and other in silico approaches to predict toxicological endpoints and support impurity assessments and lead optimization.

Quantitative exposure assessments, workplace exposure evaluations, and environmental exposure modeling for air, water, soil, and consumer products.

Structured evidence mapping and systematic review services to support hazard identification and toxicity value derivation.

Food defense consulting and training to meet Intentional Adulteration Rule requirements, including training to qualify individuals under the regulation.

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Expertise Areas

  • Toxicology and human health risk assessment
  • Exposure assessment and environmental modeling
  • Computational toxicology and (Q)SAR modeling
  • PBPK/IVIVE modeling and dosimetry
  • Show More (8)

Key Technologies

  • Physiologically based pharmacokinetic (PBPK) modeling
  • In vitro–in vivo extrapolation (IVIVE)
  • Quantitative structure–activity relationship (QSAR) modeling
  • High-throughput screening data integration (ToxCast/Tox21)
  • Show More (6)

News & Updates

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